Senior/Principal Scientist, Analytical Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Overview

Analytical Development plays a pivotal role in supporting the manufacturing process and product release of various biological modalities, including cell and gene therapies. We closely collaborate with bioprocess, formulation, data sciences, and other functions within the Bioproduct Research and Development (BRD) organization to ensure the quality and safety of bioproducts throughout their development lifecycle.

We are seeking a Senior/Principal Scientist to join the Analytical Development team in Boston, MA, to advance our islet cell therapy program. Reporting to the Senior Advisor of Analytical Development, the individual will be responsible for a wide range of bioassay development, implementation, and sample testing to support process optimization, in-process monitoring, and product release control. The successful candidate will collaborate with other functional teams at Lilly Boston and Indianapolis sites and contribute to various assay activities in a highly collaborative environment. We are looking for an individual with leadership qualities, self-motivation, and independence.

Responsibilities

• Develop and implement bioassays to support process development and lot release.  Identify and troubleshoot complex analytical issues and propose effective solutions.

• Conduct sample testing using various technical platforms (e.g., flow cytometry, cell viability, ELISA, PCR etc).  Ensure scientific data are reliable, coherent, and meet quality and regulatory expectations.

• Design, qualify, and validate bioassays to ensure their accuracy, reliability, and reproducibility for critical testing.

• Work closely with cross-functional teams, including process development, quality, diabetic research, to ensure analytical development meets project timelines and aligns with team expectations.

• Engage in implementation of preclinical study protocols and develop aligned analytical strategies to support study objectives and timelines.

• Analyze and interpret experimental data, present findings to stakeholders, and make clear and actionable recommendations to the project team.

• Support assay transfer to CDMO if needed, including technical transfer, assay qualification, troubleshooting, and data/report review.

• Oversee the lifecycle management of laboratory reagents and equipment to meet operational requirements.

• Develop and manage reference materials, ensuring their integrity and availability for analytical testing.

• Author test protocols, qualification reports, and other documents.

• Track and recommend innovative techniques to solve challenging analytical issues based on emerging scientific insights, new technologies and program needs.

Basic Requirements

• Bachelor’s or Master’s degree in biological sciences

• 1-4 years of industry experience in bioassay development.

• Hands-on experience in mammalian cell culture.

Additional Preferences

• Hand-on experience with flow cytometry, PCR, ELISA/Western Blot or fluorescence-based techniques preferred.

• Familiarity with data analysis software (e.g., Prism, FlowJo, Excel) and laboratory information management systems (e.g., Benchling).

• Demonstrated ability to troubleshoot complex analytical issues and propose innovative solutions.

• Working knowledge of ICH guidelines and industry best practices related to analytical methods. 

• Ability to set priorities and effectively manage workflows and deliverables to meet stringent timeline.

• Excellent critical thinking, problem-solving and written and verbal communication skills.

• Proven ability to work collaboratively and deliver in a matrixed environment.​

• Willing to take on additional responsibilities as needed.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$84,000 - $154,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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